Ketogenic Diet for Recurrent Glioblastoma (ERGO)

This study has been completed.
Sponsor:
Collaborator:
Evomed MedizinService GmbH
Information provided by (Responsible Party):
J. Rieger, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00575146
First received: December 17, 2007
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

To determine whether a mild ketogenic diet can influences quality of life and survival of patients with recurrent glioblastoma


Condition Intervention Phase
Recurrent Glioblastoma
Dietary Supplement: TAVARLIN
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ketogenic Diet for Patients With Recurrent Glioblastoma

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability [ Time Frame: until progression for up to 12 months ] [ Designated as safety issue: Yes ]
    percentage of patients who discontinued diet due to intolerability


Secondary Outcome Measures:
  • Progression-free-survival [ Time Frame: until progression for up to 12 months ] [ Designated as safety issue: No ]
    measured by Macdonald-Criteria

  • Overall Survival [ Time Frame: death/last contact, an average of about 1 year ] [ Designated as safety issue: No ]
    Participants were followed until reported death or last contact until 05/2011

  • Frequency of Seizures [ Time Frame: while on study treatment for up to 12 months ] [ Designated as safety issue: No ]
  • Ketosis [ Time Frame: while on study treatment for up to 12 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: while on study treatment for up to 12 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ketogenic diet
Dietary Supplement: TAVARLIN
ketogenic diet, dietary supplementary products provided by TAVARLIN

Detailed Description:

Increased glycolysis and reduced oxidative phosphorylation is a characteristic property of many tumors. A change of nutrition by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and therefore inhibit tumor growth. Standard treatment for glioblastoma includes resection, irradiation and temozolomide chemotherapy. If there is tumor recurrence, no standard therapy is established. Therapeutic options in this situation include resection, irradiation or another chemotherapy. However, some patients cannot be treated in this situation, because none of the available treatment options seems reasonable or applicable, for example if no additional chemotherapy can be started at the time of recurrence due to myelosuppression. The pilot study examines whether in this situation a ketogenic diet can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >= 18 years
  • histological diagnosis of glioblastoma or gliosarcoma
  • on MRI measurable tumor
  • interval of at least 6 months after primary resection
  • completed radiotherapy, interval of at least 3 months after completion of radiotherapy
  • relapse during or after temozolomide chemotherapy, other chemotherapy not possible, not reasonable or not wanted by the patient
  • Karnofsky-Index >= 60%, ECOG <= 2
  • life expectancy of at least 12 weeks
  • creatinine <= 1.5 mg/dl, urea <= 50 mg/dl
  • INR <= 1,5, GOT <= 7 x of normal value, GPT <= 7 x of normal value

Exclusion Criteria:

  • bowel obstruction or subileus
  • diabetes mellitus, HbA1c > 6,1 %
  • heart failure (NYHA > 2), myocardial infarction within the last 6 months, atrial fibrillation
  • acute infection
  • conditions that may strongly reduce compliance to the diet or increase risk of the diet
  • dementia or clinically relevant alterations of the mental state which interfere with the applicability of the diet
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575146

Locations
Germany
Senckenberg Institute of Neurooncology
Frankfurt, Germany, 60528
Department of General Neurology and Hertie-Institute of Clinical Brain Research, University of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Evomed MedizinService GmbH
Investigators
Principal Investigator: Johannes Rieger, MD Senckenberg Institute of Neurooncology, University of Frankfurt
  More Information

Publications:
Responsible Party: J. Rieger, Dr. Johannes Rieger, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00575146     History of Changes
Other Study ID Numbers: ERGO
Study First Received: December 17, 2007
Results First Received: June 18, 2013
Last Updated: April 16, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:
glioblastoma
ketogenic diet

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 24, 2014